Anaplastic Lymphoma Kinase (ALK) is a receptor tyrosine kinase belonging to an insulin receptor family (Non Patent Literature 1, Non Patent Literature 2). It is reported that abnormality of ALK gene causes the production of an abnormal kinase due to a fusion with another gene.
As diseases accompanying abnormality of ALK, for example, cancer and cancer metastasis (Non Patent Literature 1, Patent Literature 1); and depression and cognitive dysfunction (Non Patent Literature 2) are known. Providing an ALK inhibitor means providing an effective therapeutic and prophylactic agent for these diseases.
As a compound having an ALK inhibitory action, for example, a compound of the name of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile represented by formula (I) is known (Patent Literature 2, Patent Literature 3, Patent Literature 4).

Such a chemical compound is desirably developed as an orally-available dosage form as a medicinal agent; however, whether or not a medicinal agent can be developed as an oral formulation varies depending upon whether bioavailability of a medicinal substance is high or not. A factor influencing bioavailability is water solubility of a medicinal substance. Generally, compounds less soluble or insoluble in water are low in bioavailability if they are orally administered. Improving bioavailability of an active ingredient to thereby improve oral absorbability is important for the active ingredient to stably show its efficacy.
In the meantime, to increase the blood level of a medicinal substance less soluble or insoluble in water, thereby increasing a therapeutic effect, it is considered that the medicinal substance is used in a high dose. However, to improve patient's convenience, it is desired that the number of pills per administration and the administration times of an oral formulation are reduced. Accordingly, it is required to develop a formulation containing a large amount of a medicinal substance per unit.
A composition in which the compound represented by by formula (I) or a salt thereof is present together with a solubilizing agent has been reported (Patent Literature 4). For improving solubility and oral absorbability of a less water soluble or insoluble compound, a composition containing a component such as a steroid less soluble in water, a surfactant and an organic polymer and obtained by wet granulation in the presence of water, is reported (Patent Literature 5).